ASPIJECT

Basic Information

• Brand Name: ASPIJECT
• Primary DI: 05713513000010
• Version / Model: 2055
• Company Name: Rønvig Dental Manufacturing A/S
• Labeler DUNS: 307549241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-25
• Public Version: 4
• Public Version Date: 2018-11-22
• Public Version Status: Update
• Public Device Record Key: 90dcc8e2-a6e6-44de-b3c9-eacab96346d3

Device Description

Self-aspirating dental injection syringe for 1.8 ml standard dental cartridges

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EJI	Syringe, Cartridge	Dental	872.6770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35969	Dental anaesthesia syringe, reusable	A hand-held manual dental instrument consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle; a needle is not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05713513000010	GS1

Premarket Submissions

Submission Number	Supplement Number
K002168	000

Device Sizes

Type	Value	Unit	Text
Total Volume	1.8	Milliliter